A Trial to Compare Prophylaxis Therapy to On-demand Therapy With a New Full Length Recombinant FVIII in Patients With Severe Hemophilia A

Completed · Phase 3

Conditions studied: Hemophilia A

In brief

The objective of the trial is to demonstrate that 2-3 times per week prophylaxis therapy with BAY81-8973 is superior to on-demand therapy with BAY81-8973 in patients with severe Hemophilia A. The hypothesis is that prophylaxis will result in fewer bleeds than on-demand treatment.

Key facts

Study ID

NCT01233258

Run by

Bayer

People needed

80

Starts

2011-01-01

Expected to finish

2012-12-01

Last updated by the study team

2016-11-28

Who can join

Age: 12 and older, up to 65. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male, aged 12 to 65 years
• Severe hemophilia A
• History of more than 150 exposure days (ED) with clotting factor concentrates
• Currently receiving episodic treatment with FVIII; no regular prophylaxis for more than 6 consecutive months in the past 5 years
• No current Factor VIII inhibitor or history of inhibitor
• Willing to use electronic patient diary

You may not qualify if…

• Presence of another bleeding disease that is different from hemophilia A
• Thrombocytopenia
• Abnormal renal function
• Presence of active liver disease
• Known hypersensitivity to FVIII

Where it is running

• Study site — Dayton, Ohio, United States
• Study site — Houston, Texas, United States
• Study site — Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
• Study site — Corrientes, Corrientes Province, Argentina
• Study site — Rosario, Santa Fe Province, Argentina
• Study site — Guangzhou, Guangdong, China
• Study site — Suzhou, Jiangsu, China
• Study site — Beijing, China
• Study site — Shanghai, China
• Study site — Tianjin, China
• Study site — Bogotá, Bogota D.C., Colombia
• Study site — Bucaramanga, Santander Department, Colombia
• Study site — Olomouc, Czechia
• Study site — Hyderabad, India
• Study site — Jakarta, Indonesia
• Study site — Hiroshima, Hiroshima, Japan
• Study site — Nishinomiya, Hyōgo, Japan
• Study site — Kashihara, Nara, Japan
• Study site — Shinjuku-ku, Tokyo, Japan
• Study site — Suginami, Tokyo, Japan
• Study site — Guadalajara, Jalisco, Mexico
• Study site — San Luis Potosí City, San Luis Potosí, Mexico
• Study site — Timișoara, Timiș County, Romania
• Study site — Baia Mare, Romania
• Study site — Bucharest, Romania

Full record on ClinicalTrials.gov

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